Functional near-infrared spectroscopy as biofeedback to assist pelvic floor muscle training: a randomized controlled trial.

Withdrawn

Conditions: stress urinary incontinence.
Urine leakage
10004994

Registration Number: NL-OMON50823

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

- Referred for physical therapy to treat mixed (predominant SUI) or SUI.
- Right-handed.
- Female, between the age of 18 up to and including 60 years old.
- Signed informed consent.

Exclusion Criteria

- Using any medication for urinary complaints.
- Using any medication which may influence the function of the lower urinary
tract (i.e. neuroleptics, anti-depressants, morphine-like medication).
- Having had PFMT in the past six months.
- Any known neurological disorder.
- Any known psychiatric disorder.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is change in cortical activation during pelvic floor<br /><br>muscle contraction. Activation is measured as the oxygenated/deoxygenated<br /><br>haemoglobin ratio in the cerebral cortex, measured with fNIRS.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcomes are: change in pelvic floor muscle force, change in<br /><br>pelvic floor muscle endurance, and change in pelvic floor muscle coordination<br /><br>which are measured with EMG using the MAPLe device. The correlation between<br /><br>fNIRS and pelvic floor EMG, change in pelvic floor related quality of life, and<br /><br>change in symptom severity (frequency of incontinence episodes) are additional<br /><br>secondary outcomes. These secondary outcomes will be assessed with validated<br /><br>questionnaires on symptoms and quality of life in pelvic health. The validated<br /><br>Dutch PRAFAB, UDI-6, IIQ-7, EQ-5D-5L, and HADS will be used to assess pelvic<br /><br>health related symptoms and quality of life. These outcome measures will be<br /><br>assessed at baseline and after six weeks.</p><br>